Download as PDF
19764
Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices
ensures notification to the FTC of
changes in corporate status and
mandates that Respondents submit an
initial compliance report to the FTC.
Part VII requires Respondents to retain
documents relating to its compliance
with the order for a five (5) year period.
Part VIII mandates that Respondents
make available to the FTC information
or subsequent compliance reports, as
requested. Part IX is a provision
‘‘sunsetting’’ the order after twenty (20)
years, with certain exceptions.
The purpose of this analysis is to aid
public comment on the proposed order.
It is not intended to constitute an
official interpretation of the complaint
or proposed order, or to modify in any
way the proposed order’s terms.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2018–09545 Filed 5–3–18; 8:45 am]
BILLING CODE 6750–01–P
FEDERAL TRADE COMMISSION
[File No. 181 0017]
Amneal Holdings, LLC, and Impax
Laboratories, Inc.; Analysis to Aid
Public Comment
Federal Trade Commission.
Proposed Consent Agreement.
AGENCY:
ACTION:
The consent agreement in this
matter settles alleged violations of
federal law prohibiting unfair methods
of competition. The attached Analysis to
Aid Public Comment describes both the
allegations in the complaint and the
terms of the consent order—embodied
in the consent agreement—that would
settle these allegations.
DATES: Comments must be received on
or before May 29, 2018.
ADDRESSES: Interested parties may file a
comment online or on paper, by
following the instructions in the
Request for Comment part of the
SUPPLEMENTARY INFORMATION section
below. Write: ‘‘In the Matter of Amneal
Holdings, LLC, and Impax Laboratories,
Inc.; File No. 181 0017’’ on your
comment, and file your comment online
at https://ftcpublic.commentworks.com/
ftc/amnealimpaxdivest by following the
instructions on the web-based form. If
you prefer to file your comment on
paper, write ‘‘In the Matter of Amneal
Holdings, LLC, and Impax Laboratories,
Inc.; File No. 181 0017’’ on your
comment and on the envelope, and mail
your comment to the following address:
Federal Trade Commission, Office of the
Secretary, 600 Pennsylvania Avenue
NW, Suite CC–5610 (Annex D),
amozie on DSK3GDR082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:16 May 03, 2018
Jkt 244001
Washington, DC 20580, or deliver your
comment to the following address:
Federal Trade Commission, Office of the
Secretary, Constitution Center, 400 7th
Street SW, 5th Floor, Suite 5610 (Annex
D), Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT: Kari
Wallace (202–326–3085), Bureau of
Competition, 600 Pennsylvania Avenue
NW, Washington, DC 20580.
SUPPLEMENTARY INFORMATION: Pursuant
to Section 6(f) of the Federal Trade
Commission Act, 15 U.S.C. 46(f), and
FTC Rule 2.34, 16 CFR 2.34, notice is
hereby given that the above-captioned
consent agreement containing consent
orders to divest and providing for other
relief to resolve the allegations in the
complaint, having been filed with and
accepted, subject to final approval, by
the Commission, has been placed on the
public record for a period of thirty (30)
days. The following Analysis to Aid
Public Comment describes the terms of
the consent agreement, and the
allegations in the complaint. An
electronic copy of the full text of the
consent agreement package can be
obtained from the FTC Home Page (for
April 27, 2018), on the World Wide
Web, at https://www.ftc.gov/newsevents/commission-actions.
You can file a comment online or on
paper. For the Commission to consider
your comment, we must receive it on or
before May 29, 2018. Write ‘‘In the
Matter of Amneal Holdings, LLC, and
Impax Laboratories, Inc.; File No. 181
0017’’ on your comment. Your
comment—including your name and
your state—will be placed on the public
record of this proceeding, including, to
the extent practicable, on the public
Commission website, at https://
www.ftc.gov/policy/public-comments.
Postal mail addressed to the
Commission is subject to delay due to
heightened security screening. As a
result, we encourage you to submit your
comments online. To make sure that the
Commission considers your online
comment, you must file it at https://
ftcpublic.commentworks.com/ftc/
amnealimpaxdivest by following the
instructions on the web-based form. If
this Notice appears at http://
www.regulations.gov/#!home, you also
may file a comment through that
website.
If you prefer to file your comment on
paper, write ‘‘In the Matter of Amneal
Holdings, LLC, and Impax Laboratories,
Inc.; File No. 181 0017’’ on your
comment and on the envelope, and mail
your comment to the following address:
Federal Trade Commission, Office of the
Secretary, 600 Pennsylvania Avenue
NW, Suite CC–5610 (Annex D),
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
Washington, DC 20580, or deliver your
comment to the following address:
Federal Trade Commission, Office of the
Secretary, Constitution Center, 400 7th
Street SW, 5th Floor, Suite 5610 (Annex
D), Washington, DC. 20024. If possible,
submit your paper comment to the
Commission by courier or overnight
service.
Because your comment will be placed
on the publicly accessible FTC website
at https://www.ftc.gov, you are solely
responsible for making sure that your
comment does not include any sensitive
or confidential information. In
particular, your comment should not
include any sensitive personal
information, such as your or anyone
else’s Social Security number; date of
birth; driver’s license number or other
state identification number, or foreign
country equivalent; passport number;
financial account number; or credit or
debit card number. You are also solely
responsible for making sure that your
comment does not include any sensitive
health information, such as medical
records or other individually
identifiable health information. In
addition, your comment should not
include any ‘‘trade secret or any
commercial or financial information
which . . . is privileged or
confidential’’—as provided by Section
6(f) of the FTC Act, 15 U.S.C. 46(f), and
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—
including in particular competitively
sensitive information such as costs,
sales statistics, inventories, formulas,
patterns, devices, manufacturing
processes, or customer names.
Comments containing material for
which confidential treatment is
requested must be filed in paper form,
must be clearly labeled ‘‘Confidential,’’
and must comply with FTC Rule 4.9(c).
In particular, the written request for
confidential treatment that accompanies
the comment must include the factual
and legal basis for the request, and must
identify the specific portions of the
comment to be withheld from the public
record. See FTC Rule 4.9(c). Your
comment will be kept confidential only
if the General Counsel grants your
request in accordance with the law and
the public interest. Once your comment
has been posted on the public FTC
website—as legally required by FTC
Rule 4.9(b)—we cannot redact or
remove your comment from the FTC
website, unless you submit a
confidentiality request that meets the
requirements for such treatment under
FTC Rule 4.9(c), and the General
Counsel grants that request.
Visit the FTC website at http://
www.ftc.gov to read this Notice and the
news release describing it. The FTC Act
E:\FR\FM\04MYN1.SGM
04MYN1
Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices
amozie on DSK3GDR082PROD with NOTICES
and other laws that the Commission
administers permit the collection of
public comments to consider and use in
this proceeding, as appropriate. The
Commission will consider all timely
and responsive public comments that it
receives on or before May 29, 2018. For
information on the Commission’s
privacy policy, including routine uses
permitted by the Privacy Act, see
https://www.ftc.gov/site-information/
privacy-policy.
Analysis of Agreement Containing
Consent Orders To Aid Public Comment
The Federal Trade Commission
(‘‘Commission’’) has accepted, subject to
final approval, an Agreement
Containing Consent Orders (‘‘Consent
Agreement’’) from Amneal Holdings,
LLC, Amneal Pharmaceuticals LLC
(collectively, ‘‘Amneal’’), Impax
Laboratories, Inc., and Impax
Laboratories, LLC (collectively,
‘‘Impax’’) that is designed to remedy the
anticompetitive effects resulting from
Amneal’s acquisition of equity interests
of Impax. Under the terms of the
proposed Consent Agreement, the
parties are required to divest all of
Impax’s rights and assets related to the
following seven products to ANI
Pharmaceuticals, Inc. (‘‘ANI’’): Generic
desipramine hydrochloride tablets;
generic felbamate tablets; generic
aspirin and dipyridamole extended
release (‘‘ER’’) capsules; generic
diclofenac sodium and misoprostol
delayed release (‘‘DR’’) tablets; generic
ezetimibe and simvastatin immediate
release (‘‘IR’’) tablets; generic
erythromycin tablets; and generic
methylphenidate hydrochloride ER
tablets. Pursuant to the Consent
Agreement, the parties also are required
to divest all of Impax’s rights and assets
related to generic azelastine nasal spray
and generic olopatadine hydrochloride
nasal spray to Perrigo Company plc
(‘‘Perrigo’’), and to divest all of Impax’s
rights and assets related to generic
fluocinonide-E cream to G&W
Laboratories (‘‘G&W’’).
The proposed Consent Agreement has
been placed on the public record for
thirty days for receipt of comments from
interested persons. Comments received
during this period will become part of
the public record. After thirty days, the
Commission will again evaluate the
proposed Consent Agreement, along
with the comments received, to make a
final decision as to whether it should
withdraw from the proposed Consent
Agreement, modify it, or make final the
Decision and Order (‘‘Order’’).
Pursuant to agreements dated October
17, 2017, Amneal proposes to acquire
the equity interests of Impax in a series
VerDate Sep<11>2014
18:16 May 03, 2018
Jkt 244001
of transactions valued at approximately
$1.45 billion (the ‘‘Proposed
Acquisition’’). The Commission alleges
in its Complaint that the Proposed
Acquisition, if consummated, would
violate Section 7 of the Clayton Act, as
amended, 15 U.S.C. 18, and Section 5 of
the Federal Trade Commission Act, as
amended, 15 U.S.C. 45, by lessening
current competition in the following
three U.S. markets: (1) Generic
desipramine hydrochloride tablets; (2)
generic ezetimibe and simvastatin IR
tablets; and (3) generic felbamate tablets.
The Commission also alleges that the
Proposed Acquisition would violate the
aforementioned statutes by lessening
future competition in the following
seven U.S. markets: (1) Generic aspirin
and dipyridamole ER capsules; (2)
generic azelastine nasal spray; (3)
generic diclofenac sodium and
misoprostol DR tablets; (4) generic
erythromycin tablets; (5) generic
fluocinonide-E cream; (6) generic
methylphenidate hydrochloride ER
tablets; and (7) generic olopatadine
hydrochloride nasal spray. The
proposed Consent Agreement will
remedy the alleged violations by
preserving the competition that
otherwise would be eliminated by the
Proposed Acquisition.
I. The Products and Structure of the
Markets
In human pharmaceutical markets,
price generally decreases as the number
of generic competitors increases. Prices
continue to decrease incrementally with
the entry of the second, third, fourth,
and even fifth generic oral
pharmaceutical competitor.
Accordingly, the reduction in the
number of suppliers within each
relevant market has a direct and
substantial effect on pricing.
The Proposed Acquisition would
reduce current competition in the
markets for three products: (1) Generic
desipramine hydrochloride tablets; (2)
generic ezetimibe and simvastatin IR
tablets; and (3) generic felbamate tablets.
Desipramine hydrochloride, a
tricyclic antidepressant, is sold by only
three companies, other than Amneal
and Impax, in the United States:
Heritage Pharmaceuticals, Inc., Sandoz
(a subsidiary of Novartis AG), and Teva
Pharmaceutical Industries Ltd. (‘‘Teva’’).
Ezetimibe and simvastatin is used to
improve cholesterol and lower
triglycerides. Only four companies
currently sell generic ezetimibe and
simvastatin IR tablets in the United
States: Amneal, Impax, Dr. Reddy’s
Laboratories, and Teva.
Felbamate is an anticonvulsant used
in the treatment of epilepsy. For generic
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
19765
felbamate tablets, Alvogen, and Wallace
Pharmaceuticals, Inc. (‘‘Wallace’’) are
the only two companies in addition to
Amneal and Impax that sell the product
in the United States.
The Proposed Acquisition also would
reduce future competition in seven
markets in which Amneal or Impax is a
current competitor and the other is
likely to enter the market: (1) Generic
aspirin and dipyridamole ER capsules;
(2) generic azelastine nasal spray; (3)
generic diclofenac sodium and
misoprostol DR tablets; (4) generic
erythromycin tablets; (5) generic
fluocinonide-E cream; (6) generic
methylphenidate hydrochloride ER
tablets; and (7) generic olopatadine
hydrochloride nasal spray.
Aspirin and dipyridamole is an
antiplatelet therapy used to reduce the
risk of stroke. Amneal is the only
company currently selling generic
aspirin and dipyridamole ER capsules
in the United States, and Impax is one
of only a limited number of suppliers
capable of entering the market in the
near future.
Azelastine nasal spray is used to treat
seasonal allergies. Impax partners with
Perrigo to sell generic azelastine nasal
spray. In addition, Wallace and Apotex
Inc. also sell the product. Amneal, one
of a limited number of suppliers capable
of entering the market for generic
azelastine nasal spray in the near future,
already has tentative approval from the
United States Food and Drug
Administration (‘‘FDA’’).
Diclofenac sodium and misoprostol is
used to provide pain relief while
minimizing gastrointestinal side effects.
Four companies—Amneal, Teva,
Sandoz, and Exela Pharma Sciences LLC
(‘‘Exela’’)—have approved ANDAs to
sell generic diclofenac sodium and
misoprostol DR tablets in the United
States. In addition, Greenstone LLC, a
Pfizer subsidiary, sells an authorized
generic version. Sandoz does not sell its
product directly to customers and
supplies only to a private labeler. The
Exela product, marketed by both Eagle
Pharmaceuticals, Inc. and Dash
Pharmaceuticals LLC, has limited sales.
Impax, partnered with Micro Labs
Limited, is one of only a few suppliers
capable of entering the market for
generic diclofenac sodium and
misoprostol DR tablets in the near
future.
Erythromycin is an antibiotic that had
only one supplier, Arbor
Pharmaceuticals, LLC, before the FDA
approved Amneal’s ANDA for generic
erythromycin tablets in March of 2018.
Amneal is the only supplier of generic
erythromycin tablets in the United
States. Impax is one of only a few
E:\FR\FM\04MYN1.SGM
04MYN1
19766
Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices
suppliers capable of entering the market
for generic erythromycin in the near
future.
Fluocinonide-E cream, a topical
corticosteroid used to reduce swelling,
redness, itching, and allergic reactions,
is sold in generic form by Impax,
Alvogen, Sun Pharmaceutical Industries
Ltd., and Teva in the United States.
Amneal is one of very few suppliers
capable of entering the market for
generic fluocinonide-E cream in the
near future.
Methylphenidate hydrochloride is a
central nervous system stimulant used
to treat attention-deficit disorder and
attention-deficit/hyperactivity disorder.
Only four companies currently sell
generic methylphenidate hydrochloride
ER tablets in the United States: Amneal,
Mylan N.V., Teva, and Trigen Labs.
Impax is one of only a limited number
of suppliers capable of entering the
market for generic methylphenidate
hydrochloride ER tablets in the near
future.
Olopatadine hydrochloride nasal
spray is used to treat seasonal allergies.
Generic olopatadine hydrochloride
nasal spray is sold in the United States
by Sandoz, Apotex, and Impax
partnered with Perrigo. Amneal is one
of very few suppliers capable of entering
the market in the near future.
amozie on DSK3GDR082PROD with NOTICES
II. Entry
Entry into the ten markets at issue
would not be timely, likely, or sufficient
in magnitude, character, and scope to
deter or counteract the anticompetitive
effects of the Proposed Acquisition. The
combination of drug development times
and regulatory requirements, including
approval by the FDA, is costly and
lengthy.
III. Competitive Effects
The Proposed Acquisition likely
would cause significant anticompetitive
harm to consumers by eliminating
current competition between Amneal
and Impax in the markets for generic
desipramine hydrochloride tablets,
generic ezetimibe and simvastatin IR
tablets, and generic felbamate tablets.
Generic desipramine hydrochloride
tablets, generic ezetimibe and
simvastatin IR tablets, and generic
felbamate tablets are commodity
products, and prices typically are
inversely correlated with the number of
competitors in each market. As the
number of suppliers offering a
therapeutically equivalent drug
increases, the price for that drug
generally decreases due to the direct
competition between the existing
suppliers and each additional supplier.
Customers also raise concerns about
VerDate Sep<11>2014
18:16 May 03, 2018
Jkt 244001
their ability to source product at a
competitive price if one supplier
experiences manufacturing difficulties
when there are fewer competitors in the
market. The Proposed Acquisition
would combine two of the only five
companies selling generic desipramine
hydrochloride tablets, and would
combine two of the only four companies
selling generic ezetimibe and
simvastatin IR tablets and generic
felbamate tablets, likely resulting in
higher prices.
But for the proposed Consent
Agreement, the Proposed Acquisition
also is likely to delay the introduction
of beneficial competition, and
subsequent price decreases, by
eliminating future competition in seven
markets in which either Amneal or
Impax is a current competitor and the
other is likely to enter. Multiple
customers expressed concerns about the
effect of the proposed merger on the
market for generic aspirin and
dipyridamole ER capsules, in which
Amneal is the only current generic
competitor and Impax is approved to
enter. Impax is one of only three
competitors providing generic azelastine
nasal spray, and the imminent entry of
Amneal likely would allow customers to
negotiate more competitive prices and
secure adequate supply. Impax is one of
very few well-positioned entrants in the
market for generic diclofenac sodium
and misoprostol DR tablets, in which
Amneal is one of four current
competitors, and customers note that
they would benefit from additional
entry to negotiate pricing. Amneal is the
only generic erythromycin tablet
competitor, and Impax is one of a
limited number of companies with
products in development that upon
entry would allow customers to
negotiate lower prices. Amneal is the
only foreseeable entrant in the market
for generic fluocinonide-E cream, in
which Impax is one of only three
competitors. In the market for generic
methylphenidate hydrochloride ER
tablets, Amneal is one of four current
competitors and Impax is one of few
potential entrants. Finally, Amneal is
one of only a few entrants poised to
enter the market for generic olopatadine
hydrochloride nasal spray, in which
Impax is one of only three current
competitors. Absent a remedy, the
Proposed Acquisition likely would
cause U.S. consumers to pay higher
prices for the aforementioned generic
products.
IV. The Consent Agreement
As the Commission explained in its
remedy review, The FTC’s Merger
Remedies 2006–2012: A Report of the
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
Bureaus of Competition and Economics
(hereafter ‘‘The FTC Merger Remedies
Study’’) 1, products made at third-party
manufacturing sites are easier to divest
and involve less risk than the
technology transfer from in-house
manufacturing to a new facility, and
thus help ensure the success of
divestitures. As a result, in most cases,
if one of the products is developed or
manufactured by a third party, the
Commission will require divestiture of
that product.
Additionally, in mergers involving
complex pharmaceutical products that
are difficult to manufacture, the
Commission generally will require the
divestiture of an on-market product over
a pipeline product to place the greater
risk on the merging parties rather than
the public, with exceptions for
compelling and fact-specific reasons.
When such compelling, fact-specific
reasons exist, ‘‘The goal of a divestiture
is to put the product development effort
(including any pending regulatory
filings) in the hands of a new firm with
the same ability and incentive to bring
the pipeline product to market.’’ 2
The proposed Consent Agreement
conforms to this approach and remedies
the competitive concerns raised by the
Proposed Acquisition in the generic
azelastine nasal spray and generic
olopatadine hydrochloride nasal spray
markets by requiring Impax to return
any rights and assets it has to its partner
and ANDA-owner for these products,
Perrigo. The proposed Consent
Agreement remedies the competitive
concerns raised by the Proposed
Acquisition in the generic fluocinonideE cream market by requiring Impax to
return any rights and assets it has to its
partner and ANDA-owner for this
product, G&W. The parties must
accomplish these divestitures no later
than ten days after they consummate the
Proposed Acquisition.
The proposed Consent Agreement
remedies the competitive concerns
raised by the Proposed Acquisition in
seven of the markets at issue by
requiring Impax to divest all of its rights
and assets related to those products to
ANI. ANI is a pharmaceutical
corporation that develops,
manufacturers, sells, and distributes
solid oral, liquid, and topical
pharmaceutical products in the United
States. ANI’s track record in developing
1 See The FTC’s Merger Remedies 2006–2012: A
Report of the Bureaus of Competition and
Economics (Jan. 2017) at 36–37, https://
www.ftc.gov/system/files/documents/reports/ftcsmerger-remedies-2006-2012-report-bureauscompetition-economics/p143100_ftc_merger_
remedies_2006-2012.pdf.
2 See The FTC’s Merger Remedies Study at 31.
E:\FR\FM\04MYN1.SGM
04MYN1
amozie on DSK3GDR082PROD with NOTICES
Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices
and bringing to market pipeline
products suggests that the divested
products will be placed in the hands of
a firm with the same ability and
incentive to bring the products to
market. As explained below, the
Consent Agreement helps make that
outcome more likely.
For two of the products that both
Amneal and Impax currently market,
generic desipramine hydrochloride
tablets and felbamate tablets, Impax will
assign its contract manufacturing
agreements to ANI. For the third
currently-marketed product, Amneal
will supply ANI with generic ezetimibe
and simvastatin IR tablets for two years
with the option to extend for two
additional years.
In four overlap markets in which
Amneal has an on-market product and
Impax has a product in development,
Impax will divest its rights and assets to
ANI rather than requiring Amneal to
divest its on-market, in-house
manufactured products. Each of these
product markets has specific facts that
warrant the divestiture of the Impax
rights and assets rather than the Amneal
product. Of note, three products—
generic aspirin and dipyridamole ER
capsules, generic methylphenidate
hydrochloride ER tablets, and generic
diclofenac sodium and misoprostol DR
tablets—are more complicated to
manufacture because they have
extended or delayed release
characteristics.
For generic aspirin and dipyridamole
ER capsules, Amneal is the only
manufacturer with a product on the
market. Amneal manufactures this
product in-house. Impax received FDA
approval for its ANDA in 2017 and had
expected to use a third-party
manufacturer to launch its product.
That manufacturer experienced some
manufacturing difficulties and Impax
had begun the process of developing the
means to produce the product at its own
facilities. With the divestiture, ANI will
finalize the manufacturing process and
expects to have the Impax drug on the
market soon. Nevertheless, should ANI
be unable to market its own version of
this product by October 1, 2019, ANI
has the option to source generic aspirin
and dipyridamole ER capsules from
Amneal until ANI obtains the necessary
regulatory approvals or through March
1, 2021, whichever date is earlier. This
ensures that ANI will be able to market
a competing product near the time
Impax likely would have had the
product on market, and provides the
incentive for ANI to manufacture and
market its own product. An alternative
divestiture of the Amneal product
would involve more risk and could
VerDate Sep<11>2014
18:16 May 03, 2018
Jkt 244001
jeopardize the only generic product on
the market.
The FDA approved Amneal’s ANDA
for generic methylphenidate
hydrochloride ER tablets in February
2018. Impax also has an approved
ANDA. Impax’s product is contract
manufactured, but the contract
manufacturer needs to resolve
manufacturing issues before it can
resume manufacturing the product. It
will be less risky for Impax to assign its
manufacturing contract to ANI than to
affect a technology transfer from
Amneal for this complex product, and it
will put the product in ANI’s hands,
which has the same ability and
incentive as Impax to bring
methylphenidate hydrochloride ER
tablets to market. Thus, the proposed
Order requires the divestiture of Impax’s
rights and assets to ANI.
For generic diclofenac sodium and
misoprostol DR tablets, Amneal has an
on-market in-house manufactured
product, and Impax is partnered with
Micro Labs to commercialize a
competing product. Impax holds only
marketing rights to the product; Micro
Labs is responsible for development and
manufacturing. Impax will transfer its
marketing agreement with Micro Labs to
ANI, and Micro Labs will manufacture
the product for ANI for the current
contract term.
For erythromycin tablets, Amneal
launched its product in March 2018,
and only one other competitor, Arbor
Pharmaceuticals, is currently selling
erythromycin tablets. Amneal
manufactures the erythromycin tablets
in-house. Impax is one of a few
companies developing the product, and
once approved, it plans to outsource the
manufacturing. Here, the easier-todivest product is the Impax drug in
development. Thus, Commission staff
considers it prudent to leave the inhouse Amneal-manufactured product
with the merged firm, an ongoing and
viable competitor to Arbor. Further,
Impax will transfer all of its assets
related to its development of
erythromycin tablets to ANI, which has
the same ability and incentive to bring
a competing third erythromycin tablet to
market.
The proposed Order also requires
Amneal to provide transitional services
to ANI, Perrigo, and G&W to assist them
in establishing their manufacturing
capabilities and securing all of the
necessary FDA approvals. These
transitional services include technical
assistance to manufacture the ten
products at issue in substantially the
same manner and quality employed or
achieved by Impax. It also includes
advice and training from knowledgeable
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
19767
employees of the parties. Under the
proposed Consent Agreement, the
Commission also will appoint an
Interim Monitor.
The Commission’s goal in evaluating
possible purchasers of divested assets is
to maintain the competitive
environment that existed prior to the
Proposed Acquisition. If the
Commission determines that ANI,
Perrigo, and/or G&W are not acceptable
acquirers, or that the manner of the
divestitures is not acceptable, the
proposed Order requires the parties to
unwind the sale of rights to ANI,
Perrigo, and/or G&W and then divest the
affected products to a Commissionapproved acquirer within six months of
the date the Order becomes final. The
proposed Order further allows the
Commission to appoint a trustee in the
event the parties fail to divest the
products as required.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
interpretation of the proposed Order or
to modify its terms in any way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2018–09546 Filed 5–3–18; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Center for Health Statistics
(BSC, NCHS)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
Centers for Disease Control and
Prevention (CDC), announces the
following meeting for the Board of
Scientific Counselors, National Center
for Health Statistics (BSC, NCHS). This
meeting is open to the public; however,
visitors must be processed in
accordance with established federal
policies and procedures. For foreign
nationals or non-U.S. citizens, preapproval is required (please contact
Gwen Mustaf, 301–458–4500, glm4@
cdc.gov, or Charles Rothwell, (301) 458–
4500, cjr4@cdc.gov at least 10 days in
advance for requirements). All visitors
are required to present a valid form of
SUMMARY:
E:\FR\FM\04MYN1.SGM
04MYN1

Agencies

[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Notices]
[Pages 19764-19767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09546]
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
[File No. 181 0017]
Amneal Holdings, LLC, and Impax Laboratories, Inc.; Analysis to
Aid Public Comment
AGENCY: Federal Trade Commission.
ACTION: Proposed Consent Agreement.
-----------------------------------------------------------------------
SUMMARY: The consent agreement in this matter settles alleged
violations of federal law prohibiting unfair methods of competition.
The attached Analysis to Aid Public Comment describes both the
allegations in the complaint and the terms of the consent order--
embodied in the consent agreement--that would settle these allegations.
DATES: Comments must be received on or before May 29, 2018.
ADDRESSES: Interested parties may file a comment online or on paper, by
following the instructions in the Request for Comment part of the
SUPPLEMENTARY INFORMATION section below. Write: ``In the Matter of
Amneal Holdings, LLC, and Impax Laboratories, Inc.; File No. 181 0017''
on your comment, and file your comment online at https://ftcpublic.commentworks.com/ftc/amnealimpaxdivest by following the
instructions on the web-based form. If you prefer to file your comment
on paper, write ``In the Matter of Amneal Holdings, LLC, and Impax
Laboratories, Inc.; File No. 181 0017'' on your comment and on the
envelope, and mail your comment to the following address: Federal Trade
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite
CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the
following address: Federal Trade Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex
D), Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT: Kari Wallace (202-326-3085), Bureau of
Competition, 600 Pennsylvania Avenue NW, Washington, DC 20580.
SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34,
notice is hereby given that the above-captioned consent agreement
containing consent orders to divest and providing for other relief to
resolve the allegations in the complaint, having been filed with and
accepted, subject to final approval, by the Commission, has been placed
on the public record for a period of thirty (30) days. The following
Analysis to Aid Public Comment describes the terms of the consent
agreement, and the allegations in the complaint. An electronic copy of
the full text of the consent agreement package can be obtained from the
FTC Home Page (for April 27, 2018), on the World Wide Web, at https://www.ftc.gov/news-events/commission-actions.
You can file a comment online or on paper. For the Commission to
consider your comment, we must receive it on or before May 29, 2018.
Write ``In the Matter of Amneal Holdings, LLC, and Impax Laboratories,
Inc.; File No. 181 0017'' on your comment. Your comment--including your
name and your state--will be placed on the public record of this
proceeding, including, to the extent practicable, on the public
Commission website, at https://www.ftc.gov/policy/public-comments.
Postal mail addressed to the Commission is subject to delay due to
heightened security screening. As a result, we encourage you to submit
your comments online. To make sure that the Commission considers your
online comment, you must file it at https://ftcpublic.commentworks.com/ftc/amnealimpaxdivest by following the instructions on the web-based
form. If this Notice appears at http://www.regulations.gov/#!home, you
also may file a comment through that website.
If you prefer to file your comment on paper, write ``In the Matter
of Amneal Holdings, LLC, and Impax Laboratories, Inc.; File No. 181
0017'' on your comment and on the envelope, and mail your comment to
the following address: Federal Trade Commission, Office of the
Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D),
Washington, DC 20580, or deliver your comment to the following address:
Federal Trade Commission, Office of the Secretary, Constitution Center,
400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC.
20024. If possible, submit your paper comment to the Commission by
courier or overnight service.
Because your comment will be placed on the publicly accessible FTC
website at https://www.ftc.gov, you are solely responsible for making
sure that your comment does not include any sensitive or confidential
information. In particular, your comment should not include any
sensitive personal information, such as your or anyone else's Social
Security number; date of birth; driver's license number or other state
identification number, or foreign country equivalent; passport number;
financial account number; or credit or debit card number. You are also
solely responsible for making sure that your comment does not include
any sensitive health information, such as medical records or other
individually identifiable health information. In addition, your comment
should not include any ``trade secret or any commercial or financial
information which . . . is privileged or confidential''--as provided by
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2),
16 CFR 4.10(a)(2)--including in particular competitively sensitive
information such as costs, sales statistics, inventories, formulas,
patterns, devices, manufacturing processes, or customer names.
Comments containing material for which confidential treatment is
requested must be filed in paper form, must be clearly labeled
``Confidential,'' and must comply with FTC Rule 4.9(c). In particular,
the written request for confidential treatment that accompanies the
comment must include the factual and legal basis for the request, and
must identify the specific portions of the comment to be withheld from
the public record. See FTC Rule 4.9(c). Your comment will be kept
confidential only if the General Counsel grants your request in
accordance with the law and the public interest. Once your comment has
been posted on the public FTC website--as legally required by FTC Rule
4.9(b)--we cannot redact or remove your comment from the FTC website,
unless you submit a confidentiality request that meets the requirements
for such treatment under FTC Rule 4.9(c), and the General Counsel
grants that request.
Visit the FTC website at http://www.ftc.gov to read this Notice and
the news release describing it. The FTC Act
[[Page 19765]]
and other laws that the Commission administers permit the collection of
public comments to consider and use in this proceeding, as appropriate.
The Commission will consider all timely and responsive public comments
that it receives on or before May 29, 2018. For information on the
Commission's privacy policy, including routine uses permitted by the
Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.
Analysis of Agreement Containing Consent Orders To Aid Public Comment
The Federal Trade Commission (``Commission'') has accepted, subject
to final approval, an Agreement Containing Consent Orders (``Consent
Agreement'') from Amneal Holdings, LLC, Amneal Pharmaceuticals LLC
(collectively, ``Amneal''), Impax Laboratories, Inc., and Impax
Laboratories, LLC (collectively, ``Impax'') that is designed to remedy
the anticompetitive effects resulting from Amneal's acquisition of
equity interests of Impax. Under the terms of the proposed Consent
Agreement, the parties are required to divest all of Impax's rights and
assets related to the following seven products to ANI Pharmaceuticals,
Inc. (``ANI''): Generic desipramine hydrochloride tablets; generic
felbamate tablets; generic aspirin and dipyridamole extended release
(``ER'') capsules; generic diclofenac sodium and misoprostol delayed
release (``DR'') tablets; generic ezetimibe and simvastatin immediate
release (``IR'') tablets; generic erythromycin tablets; and generic
methylphenidate hydrochloride ER tablets. Pursuant to the Consent
Agreement, the parties also are required to divest all of Impax's
rights and assets related to generic azelastine nasal spray and generic
olopatadine hydrochloride nasal spray to Perrigo Company plc
(``Perrigo''), and to divest all of Impax's rights and assets related
to generic fluocinonide-E cream to G&W Laboratories (``G&W'').
The proposed Consent Agreement has been placed on the public record
for thirty days for receipt of comments from interested persons.
Comments received during this period will become part of the public
record. After thirty days, the Commission will again evaluate the
proposed Consent Agreement, along with the comments received, to make a
final decision as to whether it should withdraw from the proposed
Consent Agreement, modify it, or make final the Decision and Order
(``Order'').
Pursuant to agreements dated October 17, 2017, Amneal proposes to
acquire the equity interests of Impax in a series of transactions
valued at approximately $1.45 billion (the ``Proposed Acquisition'').
The Commission alleges in its Complaint that the Proposed Acquisition,
if consummated, would violate Section 7 of the Clayton Act, as amended,
15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as
amended, 15 U.S.C. 45, by lessening current competition in the
following three U.S. markets: (1) Generic desipramine hydrochloride
tablets; (2) generic ezetimibe and simvastatin IR tablets; and (3)
generic felbamate tablets. The Commission also alleges that the
Proposed Acquisition would violate the aforementioned statutes by
lessening future competition in the following seven U.S. markets: (1)
Generic aspirin and dipyridamole ER capsules; (2) generic azelastine
nasal spray; (3) generic diclofenac sodium and misoprostol DR tablets;
(4) generic erythromycin tablets; (5) generic fluocinonide-E cream; (6)
generic methylphenidate hydrochloride ER tablets; and (7) generic
olopatadine hydrochloride nasal spray. The proposed Consent Agreement
will remedy the alleged violations by preserving the competition that
otherwise would be eliminated by the Proposed Acquisition.
I. The Products and Structure of the Markets
In human pharmaceutical markets, price generally decreases as the
number of generic competitors increases. Prices continue to decrease
incrementally with the entry of the second, third, fourth, and even
fifth generic oral pharmaceutical competitor. Accordingly, the
reduction in the number of suppliers within each relevant market has a
direct and substantial effect on pricing.
The Proposed Acquisition would reduce current competition in the
markets for three products: (1) Generic desipramine hydrochloride
tablets; (2) generic ezetimibe and simvastatin IR tablets; and (3)
generic felbamate tablets.
Desipramine hydrochloride, a tricyclic antidepressant, is sold by
only three companies, other than Amneal and Impax, in the United
States: Heritage Pharmaceuticals, Inc., Sandoz (a subsidiary of
Novartis AG), and Teva Pharmaceutical Industries Ltd. (``Teva'').
Ezetimibe and simvastatin is used to improve cholesterol and lower
triglycerides. Only four companies currently sell generic ezetimibe and
simvastatin IR tablets in the United States: Amneal, Impax, Dr. Reddy's
Laboratories, and Teva.
Felbamate is an anticonvulsant used in the treatment of epilepsy.
For generic felbamate tablets, Alvogen, and Wallace Pharmaceuticals,
Inc. (``Wallace'') are the only two companies in addition to Amneal and
Impax that sell the product in the United States.
The Proposed Acquisition also would reduce future competition in
seven markets in which Amneal or Impax is a current competitor and the
other is likely to enter the market: (1) Generic aspirin and
dipyridamole ER capsules; (2) generic azelastine nasal spray; (3)
generic diclofenac sodium and misoprostol DR tablets; (4) generic
erythromycin tablets; (5) generic fluocinonide-E cream; (6) generic
methylphenidate hydrochloride ER tablets; and (7) generic olopatadine
hydrochloride nasal spray.
Aspirin and dipyridamole is an antiplatelet therapy used to reduce
the risk of stroke. Amneal is the only company currently selling
generic aspirin and dipyridamole ER capsules in the United States, and
Impax is one of only a limited number of suppliers capable of entering
the market in the near future.
Azelastine nasal spray is used to treat seasonal allergies. Impax
partners with Perrigo to sell generic azelastine nasal spray. In
addition, Wallace and Apotex Inc. also sell the product. Amneal, one of
a limited number of suppliers capable of entering the market for
generic azelastine nasal spray in the near future, already has
tentative approval from the United States Food and Drug Administration
(``FDA'').
Diclofenac sodium and misoprostol is used to provide pain relief
while minimizing gastrointestinal side effects. Four companies--Amneal,
Teva, Sandoz, and Exela Pharma Sciences LLC (``Exela'')--have approved
ANDAs to sell generic diclofenac sodium and misoprostol DR tablets in
the United States. In addition, Greenstone LLC, a Pfizer subsidiary,
sells an authorized generic version. Sandoz does not sell its product
directly to customers and supplies only to a private labeler. The Exela
product, marketed by both Eagle Pharmaceuticals, Inc. and Dash
Pharmaceuticals LLC, has limited sales. Impax, partnered with Micro
Labs Limited, is one of only a few suppliers capable of entering the
market for generic diclofenac sodium and misoprostol DR tablets in the
near future.
Erythromycin is an antibiotic that had only one supplier, Arbor
Pharmaceuticals, LLC, before the FDA approved Amneal's ANDA for generic
erythromycin tablets in March of 2018. Amneal is the only supplier of
generic erythromycin tablets in the United States. Impax is one of only
a few
[[Page 19766]]
suppliers capable of entering the market for generic erythromycin in
the near future.
Fluocinonide-E cream, a topical corticosteroid used to reduce
swelling, redness, itching, and allergic reactions, is sold in generic
form by Impax, Alvogen, Sun Pharmaceutical Industries Ltd., and Teva in
the United States. Amneal is one of very few suppliers capable of
entering the market for generic fluocinonide-E cream in the near
future.
Methylphenidate hydrochloride is a central nervous system stimulant
used to treat attention-deficit disorder and attention-deficit/
hyperactivity disorder. Only four companies currently sell generic
methylphenidate hydrochloride ER tablets in the United States: Amneal,
Mylan N.V., Teva, and Trigen Labs. Impax is one of only a limited
number of suppliers capable of entering the market for generic
methylphenidate hydrochloride ER tablets in the near future.
Olopatadine hydrochloride nasal spray is used to treat seasonal
allergies. Generic olopatadine hydrochloride nasal spray is sold in the
United States by Sandoz, Apotex, and Impax partnered with Perrigo.
Amneal is one of very few suppliers capable of entering the market in
the near future.
II. Entry
Entry into the ten markets at issue would not be timely, likely, or
sufficient in magnitude, character, and scope to deter or counteract
the anticompetitive effects of the Proposed Acquisition. The
combination of drug development times and regulatory requirements,
including approval by the FDA, is costly and lengthy.
III. Competitive Effects
The Proposed Acquisition likely would cause significant
anticompetitive harm to consumers by eliminating current competition
between Amneal and Impax in the markets for generic desipramine
hydrochloride tablets, generic ezetimibe and simvastatin IR tablets,
and generic felbamate tablets. Generic desipramine hydrochloride
tablets, generic ezetimibe and simvastatin IR tablets, and generic
felbamate tablets are commodity products, and prices typically are
inversely correlated with the number of competitors in each market. As
the number of suppliers offering a therapeutically equivalent drug
increases, the price for that drug generally decreases due to the
direct competition between the existing suppliers and each additional
supplier. Customers also raise concerns about their ability to source
product at a competitive price if one supplier experiences
manufacturing difficulties when there are fewer competitors in the
market. The Proposed Acquisition would combine two of the only five
companies selling generic desipramine hydrochloride tablets, and would
combine two of the only four companies selling generic ezetimibe and
simvastatin IR tablets and generic felbamate tablets, likely resulting
in higher prices.
But for the proposed Consent Agreement, the Proposed Acquisition
also is likely to delay the introduction of beneficial competition, and
subsequent price decreases, by eliminating future competition in seven
markets in which either Amneal or Impax is a current competitor and the
other is likely to enter. Multiple customers expressed concerns about
the effect of the proposed merger on the market for generic aspirin and
dipyridamole ER capsules, in which Amneal is the only current generic
competitor and Impax is approved to enter. Impax is one of only three
competitors providing generic azelastine nasal spray, and the imminent
entry of Amneal likely would allow customers to negotiate more
competitive prices and secure adequate supply. Impax is one of very few
well-positioned entrants in the market for generic diclofenac sodium
and misoprostol DR tablets, in which Amneal is one of four current
competitors, and customers note that they would benefit from additional
entry to negotiate pricing. Amneal is the only generic erythromycin
tablet competitor, and Impax is one of a limited number of companies
with products in development that upon entry would allow customers to
negotiate lower prices. Amneal is the only foreseeable entrant in the
market for generic fluocinonide-E cream, in which Impax is one of only
three competitors. In the market for generic methylphenidate
hydrochloride ER tablets, Amneal is one of four current competitors and
Impax is one of few potential entrants. Finally, Amneal is one of only
a few entrants poised to enter the market for generic olopatadine
hydrochloride nasal spray, in which Impax is one of only three current
competitors. Absent a remedy, the Proposed Acquisition likely would
cause U.S. consumers to pay higher prices for the aforementioned
generic products.
IV. The Consent Agreement
As the Commission explained in its remedy review, The FTC's Merger
Remedies 2006-2012: A Report of the Bureaus of Competition and
Economics (hereafter ``The FTC Merger Remedies Study'') \1\, products
made at third-party manufacturing sites are easier to divest and
involve less risk than the technology transfer from in-house
manufacturing to a new facility, and thus help ensure the success of
divestitures. As a result, in most cases, if one of the products is
developed or manufactured by a third party, the Commission will require
divestiture of that product.
---------------------------------------------------------------------------
\1\ See The FTC's Merger Remedies 2006-2012: A Report of the
Bureaus of Competition and Economics (Jan. 2017) at 36-37, https://www.ftc.gov/system/files/documents/reports/ftcs-merger-remedies-2006-2012-report-bureaus-competition-economics/p143100_ftc_merger_remedies_2006-2012.pdf.
---------------------------------------------------------------------------
Additionally, in mergers involving complex pharmaceutical products
that are difficult to manufacture, the Commission generally will
require the divestiture of an on-market product over a pipeline product
to place the greater risk on the merging parties rather than the
public, with exceptions for compelling and fact-specific reasons. When
such compelling, fact-specific reasons exist, ``The goal of a
divestiture is to put the product development effort (including any
pending regulatory filings) in the hands of a new firm with the same
ability and incentive to bring the pipeline product to market.'' \2\
---------------------------------------------------------------------------
\2\ See The FTC's Merger Remedies Study at 31.
---------------------------------------------------------------------------
The proposed Consent Agreement conforms to this approach and
remedies the competitive concerns raised by the Proposed Acquisition in
the generic azelastine nasal spray and generic olopatadine
hydrochloride nasal spray markets by requiring Impax to return any
rights and assets it has to its partner and ANDA-owner for these
products, Perrigo. The proposed Consent Agreement remedies the
competitive concerns raised by the Proposed Acquisition in the generic
fluocinonide-E cream market by requiring Impax to return any rights and
assets it has to its partner and ANDA-owner for this product, G&W. The
parties must accomplish these divestitures no later than ten days after
they consummate the Proposed Acquisition.
The proposed Consent Agreement remedies the competitive concerns
raised by the Proposed Acquisition in seven of the markets at issue by
requiring Impax to divest all of its rights and assets related to those
products to ANI. ANI is a pharmaceutical corporation that develops,
manufacturers, sells, and distributes solid oral, liquid, and topical
pharmaceutical products in the United States. ANI's track record in
developing
[[Page 19767]]
and bringing to market pipeline products suggests that the divested
products will be placed in the hands of a firm with the same ability
and incentive to bring the products to market. As explained below, the
Consent Agreement helps make that outcome more likely.
For two of the products that both Amneal and Impax currently
market, generic desipramine hydrochloride tablets and felbamate
tablets, Impax will assign its contract manufacturing agreements to
ANI. For the third currently-marketed product, Amneal will supply ANI
with generic ezetimibe and simvastatin IR tablets for two years with
the option to extend for two additional years.
In four overlap markets in which Amneal has an on-market product
and Impax has a product in development, Impax will divest its rights
and assets to ANI rather than requiring Amneal to divest its on-market,
in-house manufactured products. Each of these product markets has
specific facts that warrant the divestiture of the Impax rights and
assets rather than the Amneal product. Of note, three products--generic
aspirin and dipyridamole ER capsules, generic methylphenidate
hydrochloride ER tablets, and generic diclofenac sodium and misoprostol
DR tablets--are more complicated to manufacture because they have
extended or delayed release characteristics.
For generic aspirin and dipyridamole ER capsules, Amneal is the
only manufacturer with a product on the market. Amneal manufactures
this product in-house. Impax received FDA approval for its ANDA in 2017
and had expected to use a third-party manufacturer to launch its
product. That manufacturer experienced some manufacturing difficulties
and Impax had begun the process of developing the means to produce the
product at its own facilities. With the divestiture, ANI will finalize
the manufacturing process and expects to have the Impax drug on the
market soon. Nevertheless, should ANI be unable to market its own
version of this product by October 1, 2019, ANI has the option to
source generic aspirin and dipyridamole ER capsules from Amneal until
ANI obtains the necessary regulatory approvals or through March 1,
2021, whichever date is earlier. This ensures that ANI will be able to
market a competing product near the time Impax likely would have had
the product on market, and provides the incentive for ANI to
manufacture and market its own product. An alternative divestiture of
the Amneal product would involve more risk and could jeopardize the
only generic product on the market.
The FDA approved Amneal's ANDA for generic methylphenidate
hydrochloride ER tablets in February 2018. Impax also has an approved
ANDA. Impax's product is contract manufactured, but the contract
manufacturer needs to resolve manufacturing issues before it can resume
manufacturing the product. It will be less risky for Impax to assign
its manufacturing contract to ANI than to affect a technology transfer
from Amneal for this complex product, and it will put the product in
ANI's hands, which has the same ability and incentive as Impax to bring
methylphenidate hydrochloride ER tablets to market. Thus, the proposed
Order requires the divestiture of Impax's rights and assets to ANI.
For generic diclofenac sodium and misoprostol DR tablets, Amneal
has an on-market in-house manufactured product, and Impax is partnered
with Micro Labs to commercialize a competing product. Impax holds only
marketing rights to the product; Micro Labs is responsible for
development and manufacturing. Impax will transfer its marketing
agreement with Micro Labs to ANI, and Micro Labs will manufacture the
product for ANI for the current contract term.
For erythromycin tablets, Amneal launched its product in March
2018, and only one other competitor, Arbor Pharmaceuticals, is
currently selling erythromycin tablets. Amneal manufactures the
erythromycin tablets in-house. Impax is one of a few companies
developing the product, and once approved, it plans to outsource the
manufacturing. Here, the easier-to-divest product is the Impax drug in
development. Thus, Commission staff considers it prudent to leave the
in-house Amneal-manufactured product with the merged firm, an ongoing
and viable competitor to Arbor. Further, Impax will transfer all of its
assets related to its development of erythromycin tablets to ANI, which
has the same ability and incentive to bring a competing third
erythromycin tablet to market.
The proposed Order also requires Amneal to provide transitional
services to ANI, Perrigo, and G&W to assist them in establishing their
manufacturing capabilities and securing all of the necessary FDA
approvals. These transitional services include technical assistance to
manufacture the ten products at issue in substantially the same manner
and quality employed or achieved by Impax. It also includes advice and
training from knowledgeable employees of the parties. Under the
proposed Consent Agreement, the Commission also will appoint an Interim
Monitor.
The Commission's goal in evaluating possible purchasers of divested
assets is to maintain the competitive environment that existed prior to
the Proposed Acquisition. If the Commission determines that ANI,
Perrigo, and/or G&W are not acceptable acquirers, or that the manner of
the divestitures is not acceptable, the proposed Order requires the
parties to unwind the sale of rights to ANI, Perrigo, and/or G&W and
then divest the affected products to a Commission-approved acquirer
within six months of the date the Order becomes final. The proposed
Order further allows the Commission to appoint a trustee in the event
the parties fail to divest the products as required.
The purpose of this analysis is to facilitate public comment on the
proposed Consent Agreement, and it is not intended to constitute an
official interpretation of the proposed Order or to modify its terms in
any way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2018-09546 Filed 5-3-18; 8:45 am]
BILLING CODE 6750-01-P